JP7703651B2 - Medical Devices - Google Patents

Description

(Reference to Related Applications)
This application claims priority to U.S. Patent Application No. 17/455,945, filed November 22, 2021, which is incorporated by reference, which in turn claims priority to U.S. Provisional Patent Application No. 63/248,059, filed September 24, 2021, and U.S. Provisional Patent Application No. 63/122,115, filed December 7, 2020, which are incorporated by reference.

The present disclosure relates generally to the field of knee arthroplasty, and more specifically to a kinematic alignment tibial guide transfer instrument and method configured to precisely position components of an endoprosthetic knee implant.

Total knee arthroplasty is a procedure in which an orthopedic surgeon replaces severely diseased portions of the knee joint with an artificial endoprosthetic implant intended to restore joint function and reduce pain. The procedure itself generally consists of the surgeon making a vertical midline anterior incision in a flexed knee (i.e., the knee in flexion). The surgeon then continues to dissect tissue to access the joint capsule. After the capsule is drilled, the patella is moved out of the way to expose the distal femoral condyles, cartilaginous meniscus, and proximal tibial plateau.

The surgeon then removes the cartilaginous meniscus and uses measuring instrumentation to measure and resect the distal femur and proximal tibia independently to accommodate the endoprosthetic knee implant. The resection itself often removes diseased bone areas and modifies the bone shape to better accommodate the complementary shapes of the respective implant components; that is, the resected distal femur will ultimately fit into a complementary femoral implant component and the resected proximal tibia will ultimately support a complementary tibial implant component. The surgeon selects from different sized implant components to match the size of the patient's bone.

There are several schools of thought regarding the angle at which the resection of the distal femoral condyle and proximal tibia should be made. The angle of the resection largely determines how the implant components will sit in the joint and can affect how the prosthesis will function over time.

One such idea is the kinematic alignment principle. With kinematic alignment, the surgeon attempts to restore the patient's pre-diseased natural joint line based on data made available to the surgeon both pre- and intra-operatively.

It is not surprising that surgical approaches vary even among surgeons who practice kinematic alignment techniques. Some surgeons prefer to use calipers or other measuring instrumentation to measure the dimensions of the distal femur and proximal tibia independently of one another. This approach generally offers the greatest amount of autonomy and thus allows for the greatest amount of subjectivity and variability in the placement of the resection plane (and ultimately, the placement of the implant components). Therefore, this independently referencing approach may result in the greatest amount of trial and error.

Therefore, this technique generally increases the time that the patient is under general anesthesia. This technique also increases the risk that the final placement of the joint line will not align exactly with the natural pre-morbid joint line. In extreme cases, non-alignment may encourage supplemental or revision procedures that would otherwise be avoidable. Even if the final joint line is perfectly placed, the amount of time required to calculate, resect, place, and test the kinematically aligned joint prolongs the time that the surgical field is exposed. Although surgeons typically make every effort to maintain a sterile surgical environment, prolonged procedures may nevertheless increase the risk of infection, prolong blood loss, and cause more damage to the surrounding tissue.

Other surgeons may use tools such as those disclosed in U.S. Patent Application Publication No. 2019/0231365 to improve accuracy and reduce operative time. While certainly an improvement, these tools retain an element of subjectivity and the risks associated with subjectivity. Setting up the tools and properly adjusting them also adds additional steps to the procedure. Overall, these additional steps may affect the number of patients a surgeon can see in a day. Instruments with several moving parts may also increase the time required to sterilize the instruments between procedures.

There is therefore a long felt, yet unresolved, need to overcome the shortcomings of the prior art. It is contemplated that the instruments, assemblies, kits, systems, and methods disclosed herein may be used to overcome the shortcomings of the prior art.

The problem of inaccurate placement of resection planes in knee replacement surgery and the increased procedure time associated with procedures that are highly dependent on subjective placement of the resection planes is alleviated by a distal reference coupled drill guide assembly including a femoral portion configured to engage a first femoral engagement member, a tibial portion configured to engage a first tibial engagement member, and a body connecting the femoral portion to the tibial portion, and a femoral reference instrument having a first complementary femoral engagement member configured to engage the first femoral engagement member, wherein the distal reference coupled drill guide assembly has an engagement configuration and a disengagement configuration, the engagement configuration including the first femoral engagement member engaging the first complementary femoral engagement member, and the disengagement configuration including the first femoral engagement member not engaging the first complementary femoral engagement member.

It is contemplated that the exemplary embodiments described herein may provide improved kinematic knee devices and methods.

It is further contemplated that the exemplary embodiments described herein may provide a distal reference option for communicating alignment to the tibial resection guide.

The above objectives can be achieved by providing a kinematic alignment tibial guide transfer instrument and method having the features described herein.

The above and other objects, features, aspects, and advantages of the present invention will become more apparent from the following detailed description of the present invention when considered in conjunction with the accompanying drawings.

The foregoing will become apparent from the following more particular description of exemplary embodiments of the present disclosure, as illustrated in the accompanying drawings. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the disclosed embodiments.

1-10 generally depict method steps and example devices and assemblies that may involve the use of a femoral trial having a complementary femoral engaging member, including an example interlocking drill guide.
FIG. 1 shows a femoral trial placed on the distal end of a resected femur. FIG. 2 depicts a threaded femoral linking pin that is inserted through the reference hole in the femoral trial shown in FIG. FIG. 3A is a perspective view of the elements of FIG. 2, further including spoon gap spacers interposed medially and laterally between the femoral trial and the tibial plateau of the proximal tibia. FIG. 3B is a perspective view of the elements of FIG. 2, further including spoon gap spacers interposed medially and laterally between the femoral trial and the tibial plateau of the proximal tibia. FIG. 4 is a perspective view showing the elements from FIGS. 3A and 3B, further depicting the interlocking drill guide sliding over the femoral interlocking pin with the gap spacer present. FIG. 5A is a perspective view of the element of FIG. 4, further illustrating a tibial linking pin positioned in the tibial reference hole in the linking drill guide. FIG. 5B is a perspective view of the element of FIG. 4, further illustrating a tibial linking pin positioned in the tibial reference hole in the linking drill guide. FIG. 6A is a perspective view showing the elements of FIGS. 5A and 5B, except that a snap-on spacer has been placed between the femoral trial and the tibial plateau instead of the spoon gap spacer. FIG. 6B is a perspective view showing the elements of FIGS. 5A and 5B, except that a snap-on spacer has been placed between the femoral trial and the tibial plateau instead of the spoon gap spacer. FIG. 7A is a perspective view showing the elements of FIGS. 6A and 6B with the interlocking drill guide removed and the pivoting tibial resection guide slid over the tibial interlocking pin. FIG. 7B is a side view of the elements depicted in FIG. 7A. FIG. 8 is another side view of the elements depicted in FIG. 7A with the tibial posterior slope of the tibial resection guide adjusted to match the natural slope of the patient's tibia. FIG. 9 is a perspective view of the elements depicted in FIG. 7A with the tibial linking pin removed and the pivoting tibial resection guide secured to the proximal tibia through a fixation pin in the fixation pin hole. FIG. 10 is a side view of the elements depicted in FIG. 9, except that the femoral trial has been removed and the proximal tibial resection has been performed through a slot in the pivoting tibial resection guide.

11-15 generally illustrate method steps and example devices and assemblies that include another embodiment of an example interlocking drill guide and may involve the use of a distal reference guide having a complementary femoral engaging member.
FIG. 11 is a perspective view of the knee placed in extension with the distal femur resected and distal reference gap spacers inserted medially and laterally to fill the joint space between the resected femur and the intact tibia and to determine the medial and lateral gap distances. FIG. 12A is a perspective view of a distal reference guide having a removable handle connected to a femoral portion having a medial condyle portion and a lateral condyle portion, the distal portion of each condyle portion being configured to receive a snap-on spacer. FIG. 12B is a perspective view showing the distal reference guide inserted into the gap. FIG. 12C is a perspective view of the distal reference guide positioned within the gap with the handle removed. FIG. 13A is a perspective view showing the element of FIG. 12C, further comprising an exemplary interlocking drill guide having an orientation pin inserted into the condylar portion of the distal reference guide. FIG. 13B is a perspective view of the elements shown in FIG. 13A, further depicting a tibial linking pin inserted into the tibial reference hole in the linking drill guide. FIG. 13C is a perspective view of the elements shown in FIG. 13B, further depicting the removable handle reattached to the femoral portion of the distal reference guide. FIG. 14A is a perspective view showing a pivoting tibial resection placed over the tibial linking pin remaining in the tibia with the distal gap spacer assembly and linking drill guide removed. FIG. 14B is a side view of the element shown in FIG. 14A. FIG. 14C is a side view of the elements depicted in FIG. 14B with the tibial posterior slope of the tibial resection guide adjusted to match the natural slope of the patient's tibia. FIG. 15 is a side view of the elements depicted in FIG. 14C, except that the tibial linking pin has been removed and a standard pin has been inserted into the standard fixation pin hole to fix the orientation of the pivoting tibial resection guide, and the proximal tibial resection is performed through a slot in the pivoting tibial resection guide.

16-28 generally depict method steps and example devices and assemblies that may involve the use of a distal femoral resection guide, including other embodiments of the example interlocking drill guide.
FIG. 16 is a perspective view of the knee in flexion with the distal femoral resection guide oriented on the distal femur after the distal cut has been made. FIG. 17A is a perspective view of a knee in extension, providing an exemplary embodiment of a linking drill guide configured to be engaged with a pin previously used to secure a distal femoral resection guide in a resection orientation. FIG. 17B is a perspective view of a knee in extension, in which another exemplary embodiment of an interlocking drill guide is provided that includes a blade configured to fit securely into the femoral resection slot of the distal femoral resection guide. FIG. 18 is a perspective view of a knee in extension with a gap spacer inserted into the joint space between the resected distal femur and proximal tibia, and an embodiment of an interlocking drill guide is provided. FIG. 19A is a perspective view of the elements depicted in FIG. 18, further comprising a tibial linking pin extending through the tibial portion of the linking drill guide and into the tibia. FIG. 19B is a perspective view of the element depicted in FIG. 17B, further comprising a tibial linking pin extending through the tibial portion of the linking drill guide and into the tibia. FIG. 20A is a perspective view of the tibial linking pin remaining in the tibia after all other elements have been removed. FIG. 20B is a perspective view of an exemplary spike plate remaining in the bore hole left by the tibial linking pin after the pin and all other elements have been removed. 21A is a perspective view of a pivoting tibial resection guide positioned on the tibial linking pin depicted in FIG. 20A. FIG. 21B is a perspective view of a pivoting tibial resection guide positioned on the linkage tab of the spike plate depicted in FIG. 20B. FIG. 22 is a side view of a pivoting tibial resection guide positioned on a tibial linking pin. FIG. 23 is a perspective view of the element depicted in FIG. 21B, further comprising a tibial visual tilt gauge with the locking cam in an unlocked position. FIG. 24 is a side view of the elements depicted in FIG. FIG. 25 is a side view of the elements depicted in FIG. 23 with the pivoting resection guide 40 pivoted to adjust the posterior tilt of the resection plane. FIG. 26 is a perspective view of a pivoting tibial resection guide positioned in a desired posterior tilt with the locking cam in a locked position. FIG. 27 is a perspective view of the pivoting tibial resection guide positioned at the desired posterior tilt and further showing a flared fixation pin extending through the pivoting tibial resection guide to further secure the pivoting tibial resection guide to the tibia at the desired tilt. FIG. 28 is a perspective view of a pivoting tibial resection guide positioned at a desired posterior tilt with the tibial plateau resected. FIG. 29 is a perspective view of a femoral trial, a tibial base trial, and a meniscal insert based on size standards. FIG. 30 is an anterior cross-sectional view of an exemplary pivoting tibial resection guide.

The following detailed description of the preferred embodiments is presented for illustrative purposes only to aid in understanding, and is not intended to be exhaustive or to limit the scope and spirit of the invention. The embodiments have been selected and described in order to best explain the principles of the invention and its practical application. Those skilled in the art will recognize that many modifications can be made to the invention disclosed herein without departing from the scope and spirit of the invention.

Unless otherwise noted, like reference characters designate corresponding parts throughout the several views. Although the drawings depict embodiments of various features and components according to the present disclosure, the drawings are not necessarily to scale and certain features may be exaggerated to better illustrate embodiments of the present disclosure, and such illustrations should not be construed as limiting the scope of the present disclosure.

Unless otherwise expressly stated herein, the following rules of interpretation apply herein: (a) all words used herein shall be construed as to such gender or number (singular or plural) as required in such context; (b) the singular terms "a," "an," and "the" used in this specification and the appended claims include plural references unless the context clearly indicates otherwise; (c) the antecedent "about" applied to a recited range or value indicates an approximation having a deviation of the range or value known in the art or expected from measurement; (d) unless otherwise stated, the words "herein," "hereby," "hereinbefore," and "hereinafter," and words of similar import, refer to this specification as a whole and not to any particular paragraph, claim, or other subdivision; (e) the explanatory headings are merely for convenience and do not control or affect the meaning of any portion of this specification. (f) "Or" and "any" are not exclusive, and "include" is not limiting. Further, the words "comprising," "having," "including," and "containing" are to be construed as open-ended terms (i.e., meaning "including, but not limited to").

References herein to "one embodiment," "an embodiment," "exemplary embodiment," and the like indicate that the described embodiment may include a particular feature, structure, or characteristic, but not all embodiments may necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Moreover, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is implied that it is within the knowledge of one of ordinary skill in the art to affect such feature, structure, or characteristic in connection with other embodiments, whether or not expressly described.

To the extent necessary to provide descriptive support, the subject matter and/or text of the appended claims are incorporated herein by reference in their entirety.

The recitation of ranges of values herein is merely intended to serve as a shorthand method of individually referring to each separate value within any subrange therebetween, unless expressly stated otherwise herein. Each separate value within a recited range is incorporated into the specification or claims as if each separate value were individually recited herein. When a specific range of values is provided, it is understood that each intervening value, to the nearest tenth of the unit of the lower limit between the upper and lower limits of that range, and any other stated or intervening value within the stated range of that subrange, is included herein, unless the context clearly dictates otherwise. All subranges are also included. The upper and lower limits of these smaller ranges are also included therein, subject to any specifically and explicitly excluded limitations in the stated range.

It should be noted that some of the terms used herein are relative terms. For example, the terms "upper" and "lower" are relative to one another in location, i.e., the upper component is higher than the lower component in each orientation, but these terms may change if the orientation is reversed. The terms "inlet" and "outlet" are relative to the fluid flowing therethrough for a given structure, e.g., fluid flows into a structure through an inlet and then out of the structure through an outlet. The terms "upstream" and "downstream" are relative to the direction in which fluid flows through various components before flowing through the downstream component.

The terms "horizontal" and "vertical" are used to indicate directions relative to an absolute reference, i.e., the earth's surface level. However, these terms should not be interpreted as requiring structures to be absolutely parallel or absolutely perpendicular to one another. For example, a first vertical structure and a second vertical structure are not necessarily parallel to one another. The terms "top" and "bottom" or "base" are used to refer to a place or surface where the top is always higher than the bottom or base, relative to an absolute reference, i.e., the earth's surface. The terms "upward" and "downward" are also relative to an absolute reference. An upward flow always opposes the earth's gravity.

There are many reasons why a patient may undergo total knee arthroplasty ("TKA"). Such reasons may include trauma, progression of degenerative bone disease, and excessive wear over time and robust use. Common degenerative bone diseases include rheumatoid arthritis and osteoarthritis.

In a primary TKA (i.e., a TKA in which the surgeon operates on a knee joint that has not been previously operated on), the surgeon generally makes a vertical midline incision on the anterior side of the knee to be operated on. The incision is generally made with the knee in flexion at or below the tibial tuberosity and may extend several inches above the patella. The surgeon then continues to dissect the fatty tissue to expose the anterior surface of the joint capsule. A medial parapatellar arthrotomy may be performed to perforate the joint capsule and resect the medial patellar retinaculum. A retractor is then typically used to move the patella laterally to expose the cartilaginous meniscus that rests on the distal condyle of the femur and the proximal tibial plateau. The surgeon then removes the meniscus and uses measuring instrumentation to measure and resect the distal femur and proximal tibia. The resected distal femur and resected proximal tibia will ultimately house the endoprosthetic knee implant.

The type of measurement and resection instrumentation used may be influenced by the surgeon's preference for a particular joint alignment philosophy. These joint alignment philosophies may influence the design of available knee endoprostheses and their associated instrumentation. The three primary knee alignment principles are known respectively as anatomical alignment, mechanical alignment, and kinematic alignment.

The oldest alignment philosophy is the anatomical alignment principle. In anatomical alignment, the surgeon attempts to resect the tibia in 3 degrees of varus, regardless of the patient's actual pre-morbid joint line orientation. Femoral resections and ligament releases are also performed to maintain a straight hip-knee-ankle axis of the limb. Releasing the anterior cruciate ligament (ACL) to accommodate the implant can result in the patient feeling weak, as explained further below. Furthermore, implant technology at the time was not yet prepared to address the effects of a 3-degree varus resection of the tibia. For example, the varus angle creates shear forces between the tibial implant, the meniscal insert, and the femoral implant, which contributed to the implant failure.

The resection angle of the distal femur essentially sets the angle of the axis of the prosthesis. Anatomical alignment does not allow the angle of the resection to vary indefinitely. This can result in a resection angle that does not align with the natural angle of the patient's pre-diseased joint. As a result, anatomical alignment can result in patient discomfort, weakening of the surrounding soft tissues (e.g., ligaments and muscles), and premature wear of the prosthesis.

In mechanical alignment, the surgeon resects the tibia perpendicular to the mechanical axis of the tibia. The mechanical axis of the tibia generally refers to the axis that extends from the center of rotation of the proximal head of the associated femur through the center of the knee to the center of the ankle. Perpendicular resection of the proximal surface of the tibia to the mechanical axis results in a resection that is flush with the transverse plane placed in the resection area. Many tibial prostheses designed for mechanical alignment have articular surfaces that are configured to sit on the resected tibial plateau and place a new joint line parallel to the transverse plane of the resection. That is, the reconstructed joint line is also perpendicular to the mechanical axis. Approaching the same concept from a different perspective, the mechanically reconstructed joint line can generally be visualized as being parallel to a flat floor when the knee is in extension and the patient is standing. In contrast, the location of the natural joint line varies from person to person, but on average, the natural joint line has a slight varus inclination relative to the transverse plane of the patient's body.

Although mechanical alignment techniques can provide good stability when the patient's leg is in extension (e.g., when the patient is standing), and sometimes this technique is required due to trauma or severe disease progression, implants commonly used with mechanical alignment often require release of the ACL. In some situations, the posterior cruciate ligament (PCL) may also be released. The ACL normally prevents the tibia from sliding too far forward and from rotating too far relative to the femur. The absence of either of these ligaments can result in a feeling of weakness when the leg is in flexion. Additionally, changing the position of the patient's natural joint line can result in discomfort. Patients who change their gait to accommodate the new joint line can chronically stress the remaining muscles, which can further exacerbate discomfort and contribute to additional musculoskeletal problems in the future.

Resection of the ACL also encourages the use of a "gap balance" technique in which the surgeon uses distractors to apply opposing forces to the tibia and femur in an attempt to set the distal cut surface of the femur parallel to the proximal cut surface of the tibia while symmetrically tensioning the remaining collateral ligaments. The remaining collateral ligaments are typically the lateral collateral ligament (LCL), which connects the femur to the lateral fibula, and the medial collateral ligament (MCL), which connects the femur to the medial tibia. By setting the distal cut surface of the femur parallel to the resected tibial plateau while evenly balancing distraction forces on the remaining collateral ligaments, it is believed that the prosthesis can be easily inserted into the gap located between the femur and tibia. It is believed that the forces of the knee in flexion and extension are evenly distributed through the prosthesis, thereby avoiding uneven wear and other complications.

However, after the distal femoral resection is performed, the anterior profile of the gap is generally trapezoidal. Surgeons are generally taught to create a rectangular gap to accommodate an endoprosthetic implant. To do this, surgeons generally release the MCL if the knee is varus and the LCL if the knee is valgus. Valgus knees are present in a minority of patients. Release of these ligaments creates scar tissue as the reattached ligaments begin to heal after successful surgery. The healed ligaments often undergo contracture as a result of scarring. Ligament releases also expose tissues to trauma, creating a source of additional bleeding and generally prolonging the patient's recovery time.

The latest alignment philosophy is the kinematic alignment principle. The kinematic alignment principle seeks to restore the patient's pre-symptomatic natural joint line by recognizing that every patient's physiology is slightly different and making actual measurements of the surgical physiology to confirm the location of the natural joint line. While nothing precludes the use of the present device in mechanical or anatomical alignment, the inventors have recognized the shortcomings of mechanical and anatomical alignment and have invented a device that is also compatible with kinematic alignment.

There are various methods for performing a kinematic alignment procedure, but all begin by referencing the distal condyle of the femur. Most methods involve an assessment of the thickness of the articular cartilage on the distal surface of the femoral condyle. The surgeon may use a caliper, a cartilage thickness gauge, such as that disclosed in U.S. Patent Application Publication No. 2019/0231365, or other instrument to measure the amount of cartilage wear. The location of the premorbid natural joint line is approximately set by the interaction between the soft tissue (e.g., articular cartilage) on the femoral condyle and the tibial plateau as supported by the underlying bone (e.g., tibia). In the absence of bone loss, knowing the premorbid cartilage thickness ultimately allows for the measurement of the premorbid joint line. For example, if the surgeon measures 2 millimeters ("mm") of wear on the medial condyle and no wear on the lateral condyle, and if the surgeon plans to use a 10 mm endoprosthetic implant, the surgeon may set a femoral resection guide on the anterior surface of the femur with the purpose of making a distal cut on the distal surface of the femoral condyle. The femoral resection guide can be angled to resect 10 mm of the distal aspect of the lateral condyle and 8 mm of the distal aspect of the medial condyle. Thus, 8 mm of medial condyle resection plus 2 mm of measured cartilage loss will accommodate 10 mm of implant on the medial side. Similarly, a 10 mm resection of the lateral condyle will accommodate 10 mm of implant on the lateral side.

The surgeon then sizes the implant using a sizing guide or sizing calipers. The surgical kit typically includes several implant size options to accommodate variations in the patient population. Once the sizing guide has been used to inform the surgeon of the appropriate implant size, the surgeon removes the sizing guide and places a 4-in-1 cutting block onto the resected distal surface of the femur. The 4-in-1 cutting block has saw slots that allow the surgeon to make an anterior cut, a posterior cut, and two chamfer cuts (see Figure 1).

The femoral implant trial (see FIG. 15a) is then placed on the resected distal end 12 of the femur 10. The femoral implant trial 15a desirably matches the sizing of the endoprosthetic implant that will be installed later. A dilation or retraction device (e.g., a gap spacer (see FIG. 4, 25a)) is then inserted into the joint gap 3 (FIG. 3A) to measure the medial and lateral dimensions of the joint gap 3.

To determine the amount of proximal tibial resection, the measured dimensions of the medial and lateral aspects of the joint gap are subtracted from the desired thickness of the resection. For example, if the surgeon plans to use a 10 mm tibial implant, with a medial gap of 3 mm and a lateral gap of 1 mm, the surgeon would orient the tibial resection guide to resect 7 mm of the medial side of the tibial plateau and 9 mm of the lateral side of the tibial plateau. It will be appreciated that with kinematic alignment techniques, release of the MCL or LCL is typically not necessary. If the distal cut surface is not initially parallel to the proximal tibial cut surface, the surgeon typically recuts the tibia until the surgeon achieves the desired rectangular joint gap.

Adjusting the position of the tibial resection guide based on the measurements of the expansion or traction device produces a calculated resection angle based on the patient's specific anatomy. Based on these measurements, the tibial resection guide is typically oriented at a varus angle relative to the transverse plane, although in some patients this angle may be valgus or close to 0°. Due to the geometry of the meniscal insert and femoral component of the endoprosthetic implant assembly, the reconstructed joint line is nearly parallel to the plane of the tibial resection. Replicating the pre-injury natural joint line is an important step in restoring balanced natural kinematics of the knee. A kinematically balanced knee avoids problems with mechanical and anatomical concepts.

Described herein are instruments, assemblies, kits, systems, and methods that may be configured for use in primary total knee arthroplasty ("TKA").

Interlocking Drill Guide Technique with Engaging Femoral Trials FIGS. 1-10 generally illustrate method steps, exemplary devices, and assemblies that may involve the use of a femoral trial including an exemplary interlocking drill guide 30 and having a first complementary femoral engaging member 13 and a second complementary femoral engaging member 13z.

1 is a perspective view depicting the resected distal end 12 of a femur 10. As shown in FIG. 1, the femur 10 is prepared using a preferred resection technique. Distal cuts, anterior/posterior cuts, and chamfer cuts are made to form distal resection surface 5, posterior resection surface 6, anterior resection surface 2, and chamfer resection surfaces 8a, 8b, respectively (see also FIG. 7B). The chamfer resection surfaces 8a, 8b include anterior chamfer resection surface 8a and posterior chamfer resection surface 8b. A 4-in-1 cutting block may desirably be used to create the posterior resection surface 6, anterior resection surface 2, and chamfer resection surfaces 8a, 8b, although it will be understood that other instrumentation may be used in place of or in addition to the 4-in-1 cutting block depending on the surgeon's preference. A femoral reference instrument 15 is provided. The depicted femoral reference instrument 15 is a femoral trial 15a having a first complementary femoral engaging member 13 and a second complementary femoral engaging member 13z in the form of femoral reference holes 13a. A trial implant such as the depicted femoral trial 15a is a trial endoprosthesis that generally has the same functional dimensions as the actual endoprosthesis, but the trial implant is designed to be temporarily installed and easily removed for the purposes of evaluating the fit of the actual endoprosthesis and for the purposes of evaluating the kinematics of the knee joint. Once the surgeon is satisfied with the sizing of the trial implant and the kinematics of the knee joint, the trial implant is typically removed and the actual implant is installed.

In other exemplary embodiments, the femoral reference instrument 15 may be a distal reference guide 15b (FIG. 12A), a distal femoral resection guide 15c (FIG. 16), a pin 15d (FIG. 17A), or any other instrument disposed on the distal end 12 or preferably in close association with the distal end 12 of the distally resected surface 5 of the surgical femur 10. These instruments may be used directly or indirectly to confirm the position of the distal surface of the resected femur 10 relative to the proximal surface of the tibia 20 of the surgical femur 10. When these instruments are used with the exemplary distal reference interlocking drill guide assembly 1, in the engaged configuration, they mechanically convey information regarding the orientation of the distal resection surface 5 of the femur to the tibia 20, directly or indirectly. In other words, when the exemplary distal reference interlocking drill guide assembly 1 is in an engaged configuration, the femoral reference instrument 15 can be used to mechanically transmit information regarding the orientation of the distal resection surface 5 of the femur directly to the tibia 20 (or indirectly through an intermediate instrument such as the pivoting tibial resection guide 40).

As shown in FIG. 2, each of the femoral reference holes 13a (i.e., the exemplary first and second complementary femoral engagement members 13 and 13z) receives a femoral linking pin 17. The tips of these femoral linking pins 17 (see the tips 11 of the flared fixation pins 34 in FIG. 9) are then placed into the distal portion of the resected femur 10. In the depicted embodiment, the femoral linking pins 17 function as the first and second femoral engagement elements 19 and 19z.

It will be appreciated that the femoral linking pin 17 may be a common pin, headless nail, drill bit, post, or other connectable fastener that is compatible with standard pin slots of related instrumentation such as the distal femoral resection guide 15c (FIG. 16), the pivoting tibial resection guide 40 (FIG. 7A), the linking drill guide 30, other drill guides, and other surgical instrumentation. It will also be appreciated that in other exemplary embodiments, the femoral linking pin 17 may have visual or tactile indicators to reduce surgeon error. Visual indicators may include different colors and markings. Visual and tactile indicators may include raised or recessed portions of the femoral linking pin 17.

1-10 show a first complementary femoral engagement member 13 in the form of a femoral reference hole 13a and a second complementary femoral engagement member 13z, it will be understood that other exemplary embodiments may include one complementary femoral engagement member 13. Still other exemplary embodiments may include three or more complementary femoral engagement members 13, 13z, etc. The complementary femoral engagement member 13 may take the form of a hole, a slot, a recess, a protrusion, a clamp, a lip, a magnet, a spike, or any other structure known in the art that is used to selectively (directly or indirectly) securely engage and disengage one component from another component, as well as any combination thereof. It will be understood that in certain exemplary embodiments, the complementary femoral engagement member 13 may be present on the distal femur 10 itself, and the femoral engagement member 19 of the coupling drill guide 30 may be configured to engage a complementary femoral engagement member 13 disposed directly on the distal femur 10. In such an exemplary embodiment, the complementary femoral engagement member 13 is likely to be a drill hole placed directly on the distal femur 10, created by a drill bit guided by a drill guide.

As shown in FIG. 2, the femoral link pin 17 is threaded through the femoral reference hole 13a of the femoral trial 15a. In certain exemplary embodiments, the femoral link pin 17 may be threaded. In such embodiments, the femoral link pin 17 is desirably threaded at the distal end (see FIG. 9) to fixedly engage the femoral link pin 17 in the bone. The femoral link pin 17 is placed in the femoral trial 15a.

As shown in Figures 3A and 3B, a widening device 49 in the form of a gap spacer 25 is inserted medially and laterally to fill the joint gap 3 defined by the area between the distal surface of the femur 10 and the proximal surface of the tibia 20. It will be understood that the gap spacer 25 may refer to any instrument that may be inserted into the space between the proximal surface of the tibia and the distal surface of the femur 10, used to measure or otherwise assess the size of the joint gap 3 (i.e., the height of the medial and lateral joint gap 3). In this manner, such a widening device is "configured to be placed" between the resected distal femur 10 and the proximal tibia 20 to ascertain the distance between the distal femur 10 and the proximal tibia 20. It will be understood that the widening device 49 may be placed in the joint gap 3 when the knee is in flexion or extension.

3A and 3B, the gap spacer 25 is a spoon gap spacer 25a. The measurement element 26 of the spoon gap spacer 25a is desirably curved to closely abut the curved surface of the femoral trial 15a. It will be appreciated that a number of gap spacers 25 having different sized measurement elements 26 are typically provided for a procedure. The different sized measurement elements 26 are typically provided in height increments of 1 mm, although other increments are contemplated. FIG. 3B shows the measurement element 26 of the inner gap spacer 25 (i.e., the gap spacer 25 depicted on the left side of the image) being thicker than the measurement element 26 of the adjacent outer gap spacer 25 (i.e., the gap spacer 25a depicted on the right side of the image).

A spoon gap spacer 25a may be provided for the left and right legs. Different embodiments of the gap spacer 25 include a snap-on spacer 25b shown in FIG. 6A, different sized trays or plugs configured to be inserted into the joint space 3, and spacers having a removable measuring element 26. Nothing in this disclosure is intended to limit the types of gap spacers 25 that are compatible with the exemplary embodiments of this disclosure.

It will be further understood that the expansion device 49 can include other ligament tensioning devices such as gap spacers 25, laminar spreaders, ratchet tensioners, or gap balancing devices. In certain exemplary methods, a traction device may be used instead of or in addition to the expansion device. While the expansion device is typically inserted into the surgical area of the knee to separate the distal femur 10 from the proximal tibia 20 at the joint space 3, the tensioning device is typically placed outside the surgical area, for example, on the patient's ankle or on the patient's leg, to pull on the surgical leg, thereby providing traction and separating the distal femur 10 from the proximal tibia 20 at the joint space 3. It will be understood that the tensioning device can include a boot configured to encapsulate a portion of the patient's leg, ankle, or foot on the surgical leg, the surgeon's or technician's hand, or other device configured to apply traction to the surgical leg.

After the distal femoral cut is made, the surgeon will selectively insert different sized spoon gap spacers 25a medially and laterally into the articular gap 3 until the measured ends of the spoon gap spacers 25a provide a secure fit. Without being bound by theory, the use of the expansion device 49 (e.g., spoon gap spacer 25a), in combination with the use of the interlocking drill guide 30, as described further below, can eliminate the need for "gap balancing" and release of either the MCL or LCL in the engaged position, thereby avoiding the risk of hematoma, unnecessary trauma to the ligaments, scarring, and increased healing time that would otherwise result from conventional mechanical alignment techniques. The expansion device 49 effectively sets the articular gap 3 at the desired distance, while the interlocking drill guide 30 communicates information regarding the orientation of the distal femoral cut to the tibial resection guide (which may be a pivoting tibial resection guide), allowing the surgeon to quickly make a tibial cut that is typically and desirably parallel to the distal femoral cut. The distal femoral cut and the proximal tibial cut effectively define a "rectangle" into which the endoprosthetic implant will be inserted.

Previously, in mechanical alignment techniques, the MCL or LCL would have been released (i.e., cut) to define a "rectangle" into which an endoprosthetic implant would have been inserted. In this manner, it is contemplated that the interlocking drill guide 30 may be used to avoid the need for "gap balancing," releasing the MCL or LCL, and the associated scarring, hematoma, trauma, and increased healing time of conventional methods. These improvements may be particularly noticeable when the exemplary interlocking drill guide 30 is used in mechanical alignment techniques.

It is contemplated that the exemplary embodiments described herein may be used in conjunction with mechanical alignment techniques, anatomical alignment techniques, kinematic alignment techniques, or any other techniques practiced by a qualified orthopedic surgeon.

FIG. 4 illustrates an exemplary distal reference interlocking drill guide assembly 1 in an engaged configuration. The exemplary distal reference interlocking drill guide assembly 1 generally includes a femoral reference instrument 15 and an interlocking drill guide 30.

The exemplary interlocking drill guide 30 has a femoral portion 32 configured to engage a first femoral engagement member 19. The first femoral engagement member 19 is in turn configured to engage a first complementary femoral engagement member 13 of the femoral reference instrument 15. The depicted interlocking drill guide 30 is further configured to engage a second femoral engagement member 19z. The second femoral engagement member 19z is configured to engage a second complementary femoral engagement member 13z (FIG. 1) of the femoral reference instrument 15. The interlocking drill guide 30 may be referred to as a "yoke" if desired.

The femoral portion 32 of the interlocking drill guide 30 has an area defining a femoral coupling hole 22 (FIG. 5A), a femoral coupling hole 22z. The femoral coupling hole 22 is an exemplary structure that allows the femoral portion 32 of the interlocking drill guide 30 to engage the first femoral engagement member 19. By having a femoral coupling hole 22 that can be positioned around the femoral coupling pin 17, the interlocking drill guide 30 can be said to "indirectly engage" the femoral reference instrument 15 via the first femoral engagement member 19, (which in the depicted embodiment takes the form of the femoral coupling pin 17), and the first complementary femoral engagement member 13, (which in the depicted embodiment takes the form of the first femoral reference hole 13a (FIG. 1)). In such an exemplary manner, the femoral portion 32 can thereby be said to be "configured to engage the first femoral engagement member 19".

Similarly, the second femoral coupling hole 22z is an exemplary structure that allows the femoral portion 32 to engage the second femoral engagement member 19z. By having the second femoral coupling hole 22z that can be positioned around the second femoral coupling pin 17, the coupling drill guide 30 can be said to "indirectly engage" the femoral reference instrument 15 via the second femoral engagement member 19z, (which in the depicted embodiment takes the form of the femoral coupling pin 17), and the second complementary femoral engagement member 13 (which in the depicted embodiment takes the form of the second femoral reference hole 13z). In such an exemplary manner, the femoral portion 32 can thereby be said to be "configured to engage the second femoral engagement member 19z."

The femoral link pin 17 and femoral link hole 22 are provided as examples of what may be provided to configure the femoral portion 32 to engage with the femoral engagement members 19, 19z, etc., but it will be understood that any mechanical engagement mechanism designed to selectively engage one component with another is considered to be within the scope of this disclosure. Furthermore, the first and second femoral reference holes 13a are provided as examples of the first and second complementary femoral engagement members 13 and 13z that are "configured to receive" the distal end of the femoral link pin 17 (e.g., femoral engagement members 19, 19z, etc.) and thereby "engage" with the femoral engagement members, but it will be understood that any mechanical engagement mechanism designed to selectively engage one component with another is considered to be within the scope of this disclosure.

It will also be appreciated that in other exemplary embodiments, the first femoral engaging member 19 is an integral part of the interlocking drill guide 30. For example, the first femoral engaging member 19 may be permanently engaged to the femoral portion 32 and may extend directly from the femoral portion 32 of the interlocking drill guide 30 (see blade 19c in FIGS. 13A and 17B). In embodiments in which the interlocking drill guide 30 includes a first femoral engaging member 19 that is permanently engaged to the femoral portion 32, such an embodiment may similarly be said to be "configured to engage the first femoral engaging member 19." The same can be said for exemplary interlocking drill guides 30 that include a second or even three or more permanently engaged femoral engaging members 19z, etc. The interlocking drill guide 30, which includes the permanently fixed femoral engagement members 19, 19z, etc., can further be said to "directly engage" the femoral reference instrument 15 via the first femoral engagement member 19 and the first complementary femoral engagement member 13.

Similarly, in embodiments in which the interlocking drill guide 30 includes a second femoral engaging member 19z, such embodiments may similarly be said to be "configured to engage with the second femoral engaging member 19z." The interlocking drill guide 30 including the second femoral engaging member 19z may further be said to "directly engage" the femoral reference instrument 15 via the second femoral engaging member 19z and the second complementary femoral engaging member 13z.

In the depicted embodiment, the first femoral engagement member 19 and the second femoral engagement member 19z are femoral link pins 17, 17z, and the first complementary femoral engagement member 13 and the second complementary femoral engagement member 13z of the distal femoral reference instrument 15 are femoral reference holes 13a.

It will be appreciated that in other exemplary embodiments, the first femoral engaging member 19 or the second femoral engaging member 19z may comprise a slot, lip, clamp, hook, protrusion, recess, spike, magnet, orientation pin 19b (FIG. 13B), blade 19c (FIG. 17B), or any other structure known in the art that is used to selectively and securely engage and disengage one component directly or indirectly with another component, as well as any combination thereof. In certain exemplary embodiments, the first femoral engaging member 19 or the second femoral engaging member 19z physically contacts the first complementary femoral engaging member 13 without an intermediate element. In such embodiments, the first femoral engaging member 19 or the second femoral engaging member 19z may be said to "directly engage" the first complementary femoral engaging member 13 or the second complementary femoral engaging member 13z. Similarly, when an intermediate element is present, the first femoral engagement member 19 or the second femoral engagement member 19z can be said to "indirectly engage" the first complementary femoral engagement member 13 or the second complementary femoral engagement member 13z.

The interlocking drill guide 30 further comprises a tibial portion 31. The tibial portion 31 has an area defining two tibial reference holes 23. It will be appreciated that in certain exemplary embodiments, only one tibial reference hole 23 may be provided. In yet other exemplary embodiments, three or more tibial reference holes 23, 23z may be provided. The body 36 connects the femoral portion 32 to the tibial portion 31. The body 36 of the interlocking drill guide 30 and the substantially parallel arrangement of the reference markings (e.g., the femoral interlocking holes 22, 22z and the tibial reference holes 23, 23z) on the respective femoral portion 32 and tibial portion 31 communicate information regarding the orientation of the distal resection surface (which is coplanar with the distal resection surface 5) to the tibial portion 31 of the interlocking drill guide 30. In certain exemplary embodiments, the body 36 may have a fixed length. A plurality of interlocking drill guides 30 may be provided, each having a body 36 having a different length than the body 36 of another interlocking drill guide 30 provided in the kit. In such an exemplary embodiment, the surgeon may select one interlocking drill guide 30 of the plurality of provided interlocking drill guides 30 to transmit information regarding the distal resection surface 5 of the femur 10 to the tibial resection guide 40 (FIG. 7A) for purposes of setting the plane of the tibial resection. In certain procedures, it is desirable for the plane of the tibial resection to be parallel to the plane of the distal resection.

In other exemplary embodiments, the body 36 can have an adjustable length dimension relative to the femoral portion 32, relative to the tibial portion 31, or relative to both the femoral portion 32 and the tibial portion 31. In yet other exemplary embodiments, the length of the femoral portion 32 or the tibial portion 31 can be adjustable relative to the body 36. In any embodiment that includes adjustment of the length of the interlocking drill guide 30, the adjustable component can desirably be locked at a desired length. It is contemplated that a kit featuring such an adjustable length interlocking drill guide may include fewer interlocking drill guides 30 than a kit that includes multiple interlocking drill guides 30 having multiple different lengths.

In certain exemplary embodiments, the interlocking drill guide 30 is provided as a single piece. It is contemplated that the single piece may be easier to sterilize between procedures and may obviate the risk of mechanical failure as compared to exemplary embodiments in which the interlocking drill guide 30 is not a single piece, but rather includes multiple components. The interlocking drill guide 30 is desirably sized to be placed anterior to the knee exposed to the surgical field. It is contemplated that the exemplary interlocking drill guide 30 described herein may reduce the overall instrumentation required to perform a TKA while allowing the surgeon to resect the proximal tibia more quickly than can be safely achieved with existing instrumentation.

Similar to the femoral coupling holes 22, 22z provided in the femoral portion 32, the first tibial reference hole 23 in the tibial portion 31 allows the tibial portion 31 to engage a first tibial engagement member 77 (FIG. 5A). The depicted embodiment includes a first tibial engagement member 77 in the form of a tibial coupling pin 27 and a second tibial engagement member 77z. By having a first tibial reference hole 23 that can be positioned around the tibial coupling pin 27, the coupling drill guide 30 can be said to be "configured to engage a first tibial engagement member 77."

Similarly, the second tibial reference hole 23z is an exemplary structure that allows the tibial portion 31 to engage the second tibial engagement member 17z. By having the second tibial reference hole 23z that can be positioned about the second tibial engagement member 77z, the tibial portion 31 can thereby be said to be "configured to engage the second tibial engagement member 77z."

In the depicted embodiment, the first tibial engagement member 77 and the second tibial engagement member 77z are tibial link pins 27, 27z.

It will be appreciated that in other exemplary embodiments, the first tibial engaging member 77 or the second tibial engaging member 77z may include slots, lips, clamps, hooks, protrusions, recesses, spikes, magnets, orientation pins, blades, or any other structure known in the art that is used to selectively and securely engage and disengage one component directly or indirectly with another component, as well as any combination thereof. In certain exemplary embodiments, the first tibial engaging member 77 physically contacts the tibia 20 without an intermediate element. In such embodiments, the first tibial engaging member 77 may be said to "directly engage" the tibia 20. In certain exemplary embodiments, it is contemplated that an intermediate element may be disposed between the tibial portion 31 and the tibia 20. In such embodiments, the first tibial engaging member 77 and the second tibial engaging member 77z may engage an intermediate component, which itself may directly engage the tibia 20. In such an embodiment, the first tibial engagement member 77 and the second tibial engagement member 77z can be said to "indirectly engage" the tibia 20.

It is contemplated that the exemplary interlocking drill guide 30 according to the present disclosure may be manufactured from (or coated with) any clinically proven biocompatible material, including stainless steel, cobalt chromium alloy, or plastic polymers such as ultra-high molecular weight polyethylene ("UHWPE"). In certain exemplary embodiments, the interlocking drill guide 30 may be a single-use, disposable interlocking drill guide. In other exemplary embodiments, the interlocking drill guide 30 may be designed for use in multiple surgical procedures. Regardless of the embodiment, the exemplary interlocking drill guide 30 is desirably sterilized prior to entering the surgical field.

4, the interlocking drill guide 30 is slid over the femoral interlocking pin 17 until the tibial portion 31 of the interlocking drill guide 30 contacts the anterior tibial cortex 21 of the proximal tibia 20. The sliding of the femoral interlocking hole 22 of the femoral portion 32 over the interlocking pin 17 extending through the femoral reference hole 13a of the femoral trial 15a in the depicted embodiment defines an engaged configuration of the distal reference interlocking drill guide assembly 1. Similarly, it will be understood that the distal reference interlocking drill guide assembly 1 is in a disengaged configuration when the femoral engagement member 19 is not directly or indirectly engaged with the complementary femoral engagement member 13. For example, in the depicted embodiment, the distal reference interlocking drill guide assembly 1 is in a disengaged configuration when the femoral interlocking hole 22 of the femoral portion 32 is not positioned around the interlocking pin 17.

Although the femoral connection hole 22 is provided as an example, it will be understood that the femoral connection hole 22 may take the form of a slot, recess, tube, protrusion, clamp, lip, magnet, spike, or any other structure known in the art that is used to selectively (directly or indirectly) securely engage and disengage one component from another component, as well as any combination thereof. It will also be understood that in embodiments in which the femoral engagement members 19, 19z, etc. are integrally engaged to the coupling drill guide 30 (see, e.g., FIGS. 13B and 17B), the femoral connection hole 22 may be absent.

The expansion device 49, such as the gap spacer 25, may be in place before sliding the interlocking drill guide 30 over the femoral linking pin 17, or the expansion device 49 may be placed in the joint gap 3 after the interlocking drill guide 30 has been slid over the femoral linking pin 17.

5A and 5B, with the spoon gap spacer 25a in place, the tibial link pin 27 is placed into each of the tibial reference holes 23, 23z, etc. of the link drill guide 30. In the depicted embodiment, the tibial reference holes 23, 23z are tibial drill holes 23a. In other exemplary embodiments, the tibial reference holes 23 can take the form of holes, slots, tubes, recesses, protrusions, clamps, lips, magnets, spikes, or any other structure known in the art that is used to selectively (directly or indirectly) securely engage and disengage one component from another component, and any combination thereof. It will also be understood that in embodiments where the tibial engagement member is integrally engaged to the link drill guide 30, the tibial reference holes 23, 23z may not be present. In certain exemplary embodiments, there may be only one tibial reference hole 23. The tibial link pin 27 is fixed to the tibia 20. In certain exemplary embodiments, the tibial link pin 27 is threaded. In such an exemplary embodiment, the tibial link pin 27 is preferably threaded at the tip 11 to fixedly engage the tibial link pin 27 into the tibia 20 (see tip 11 of flared fixation pin 34 in FIG. 9 for reference).

Alternatively, as shown in Figures 6A and 6B, a snap-on spacer 25b can be used in place of the gap spoon 25a to fill the joint gap 3. It will be appreciated that the measurement element 26 of the snap-on spacer 25b can occupy substantially the same area as the snap-on spacer 25b itself. Figure 6B provides an illustrative example of an inner snap-on spacer 25b1 that is thicker than the adjacently positioned outer snap-on spacer 25b2.

As shown in FIG. 7A, the articulating drill guide 30 is removed, leaving the femoral linking pin 17 in place in the femur 10 and the tibial linking pin 27 in place in the tibia 20. The receiving slot 87 of the pivoting tibial resection guide 40 is slid over the tibial linking pin 27. In the depicted embodiment, the receiving slot 87 extends generally anterior-posterior through the body 40a of the pivoting tibial resection guide 40. The receiving slot 87 is desirably sized to closely encompass the medial-lateral width of the tibial linking pin 27 while having a generally vertical (i.e., up-down) length dimension that allows the pivoting tibial resection guide 40 to pivot about the tibial linking pin 27 as described further below.

30 is a front cross-sectional view of an exemplary pivoting tibial resection guide 40. The pivoting tibial resection guide 40 can include a pivoting tibial resection guide body 40a. The body 40a defines a generally linear resection slot 46 disposed above a pivot recess 78. The pivot assembly 55 can be precisely sized to rotate about an axis within the pivot recess 78. The pivot assembly 55 itself is preferably disposed above a locking mechanism recess 79 that is preferably sized to closely surround the locking mechanism 48. The body 40a further includes an area defining a number of standard holes 33, a +2 mm standard pin hole 33, and a flared fixation pin receiving hole 35.

The depicted locking mechanism 48 includes a cam 73, a cam follower 74, a shaft 71 oriented substantially perpendicular to the pivot guide 66, and a spring 75 disposed between the cam follower 74 and the shaft 71. The pivot assembly 55 includes a pivot guide 66 and end screws 43 disposed at both ends of the pivot guide 66 to prevent the pivot guide 66 from sliding from the pivoting tibial resection guide 40. The pivot guide 66 desirably has one or more complementary tibial engagement members 68 that can receive the tibial engagement members associated with the drill connection guide 30. The complementary tibial engagement members 68 may include slots 68b sized to receive the connection tabs 64 (see the embodiment depicted in FIG. 20B) of the spike plate 67 and tibial engagement holes 68a disposed adjacent the outside of both of the slots 68b. However, in certain exemplary embodiments, one or more tibial engagement holes 68a may be provided in place of the slots 68b, or vice versa.

As shown in the side view of FIG. 7B, the tibial resection level is automatically set to accommodate the 10 mm tibial component (or construct) of the endoprosthesis assembly, which may include a tibial trial base 93 (FIG. 29) and a meniscal trial insert 95 (FIG. 29). In embodiments, the interlocking drill guide 30 may be fabricated to allow other resection levels as needed or desired by the surgeon, such as with multiple interlocking drill guides 30, multiple pin holes on the interlocking drill guide 30, multiple interlocking holes on the pivoting tibial resection guide 40, or adjustable interlocking drill guides 30.

As shown in FIG. 8, the tibial posterior slope PS can be adjusted as needed to match the natural anatomy. The pivoting tibial resection guide 40 is configured so that it can be adjusted relative to the placement of the tibial linking pin 27 in the tibia 20. The tibial posterior slope PS can be generally envisioned as a plane extending anterior-posterior, medial and lateral, and passing through the resection slot 46. In FIG. 8, a side view of this plane is depicted as a line. The intersection of the tibial posterior slope PS with a transverse plane TP that extends approximately horizontally through the tibia 20 defines a posterior slope angle θ. The placement of the transverse plane TP can be measured from any frame of reference useful for defining the posterior slope angle θ. In the depicted embodiment, the transverse plane TP is positioned coplanar with the tibial linking pin 27 extending into the tibia 20. In the side view of FIG. 8, the transverse plane TP is depicted as a line. In an embodiment, the pivoting tibial resection guide 40 can be adjusted from about minus 3 degrees to about plus 10 degrees relative to the tibial linking pin 27. Once the desired tibial posterior slope PS is reached, the pivoting tibial resection guide 40 can be locked into place using the locking mechanism 48 of the pivoting tibial resection guide 40.

As shown in FIG. 9, once the posterior slope PS is set to the desired posterior slope angle θ, the pivoting tibial resection guide 40 is pinned in place by inserting the pin 37 through the standard pin hole 33 and into the tibia 20. The depicted standard pin hole 33 includes a 10 mm pin hole that is located below and slightly offset from the +2 mm standard pin hole 33. The pin 37 extends through the standard pin hole 33 in FIG. 9. The +2 mm standard pin hole 33 can be used if the sizing guide indicates that the patient's anatomy will require a tibial construct larger than the standard 10 mm (i.e., meniscus trial insert 95 and tibial trial base 93, see FIG. 29). However, in common practice, if the amount of tibial resection was insufficient to allow for a 10 mm tibial construct, the pivoting tibial resection guide 40 would more likely be placed back on the pin 37 in the +2 mm standard pin hole 33. It will be appreciated that other exemplary pivoting tibial resection guides 40 may have more than four pin holes 33. All feasible increments between standard pin holes 33 are considered within the scope of this disclosure.

9, the tibial linking pins 27 have been removed from the receiving slots 87 of the pivoting tibial resection guide 40. The pins 37 extend through standard pin holes 33 into the tibia 20 and generally prevent further pivoting. Rather, these pins 37 can be used to lock the pivoting tibial resection guide 40 in a desired orientation. As shown, a flared fixation pin 34 can be used for added stability, if desired. The tip 11 of the flared fixation pin 34 extends into the anterior tibial cortex 21 of the proximal tibia 20.

As illustrated with reference to FIG. 9, other resection levels of the proximal tibia 20 can also be achieved using multiple standard pin holes 33 located at different resection levels. Sliding the standard pin holes 33 located at different heights of the pivoting tibial resection guide 40 across the resection levels changes the position of the resection slot 46 upward and downward relative to the top of the tibial plateau, thereby allowing the surgeon to adjust the amount of resection to accommodate different sized endoprosthetic implant assemblies.

As shown in FIG. 10, the femoral trial 15a is removed and the proximal tibial resection is performed through the resection slot 46 of the pivoting tibial resection guide 40. The surgeon typically performs the resection using a handheld surgical saw inserted through the resection slot 46. In another exemplary embodiment, the surgeon can use the top of the pivoting tibial resection guide 40 as a plane to align the proximal tibial resection.

Once the tibial resection is complete, the surgeon selects the appropriately sized tibial trial base 93 and meniscal trial insert 95. The femoral trial 15a is then repositioned onto the resected distal end 12 of the femur 10 and a trial reduction is performed. Femoral grooves, peg preps, and tibial keel preps can be performed according to kinematic alignment techniques or surgeon preference.

Distal Referencing Technique FIGS. 11-15 generally illustrate method steps and exemplary devices and assemblies including another exemplary interlocking drill guide 30, in which the femoral reference instrument 15 is a distal reference guide 15b having a complementary femoral engaging member 13.

11 is a perspective view of a knee positioned in extension, with the distal femur 10 resected and spoon gap spacers 25a inserted medially and laterally to fill the joint space between the resected femur 10 and the intact tibia 20 and determine the medial and lateral gap distances. The surgeon or technician then selects a snap-on spacer 25b from a number of available snap-on spacers 25b, where a first snap-on spacer has a different thickness than another available snap-on spacer 25b. Once the appropriate thickness of the snap-on spacer 25b is selected, the fully assembled distal reference guide 15b will match the gap distance d determined in the step of using the spoon gap spacer 25a (see FIG. 11).

In certain exemplary methods, the use of the spoon gap spacer 25a can be omitted and a distal reference guide 15b having a snap-on gap spacer 25b selectively selected to match the distance of the medial and lateral dimensions of the joint gap 3 can be used in place of the spoon gap spacer 25a.

In a particular exemplary method, the pivoting tibial resection guide 40 can also be used in a distal referencing technique. At the start of the distal referencing technique, the distal end 12 of the femur 10 is resected. Distal, anterior, posterior, and chamfer cuts are made to form distal resection surface 5, posterior resection surface 6, anterior resection surface 2, and chamfer resection surface 8a, 8b, respectively (see also FIG. 14B). U.S. Patent Application Publication No. 2019/0231365 (A1), incorporated herein by reference, provides an example of how a surgeon may orient the distal, anterior, posterior, and chamfer cuts. As shown in FIG. 12B, after the distal resection, the knee is placed in extension and the distal reference guide 15b is inserted into the joint space 3. In the depicted embodiment, the distal reference guide 15b comprises a distal reference portion 44, a modular handle 41, and a snap-on gap spacer 25b disposed on the bottom side of the distal reference portion 44.

As seen in FIG. 12A, the snap-on gap spacer 25b is affixed to the distal reference portion 44 of the distal reference guide 15b. The surgeon uses the modular handle 41 to insert the reference portion 44 medially and laterally between the distal surface of the resected femur 10 and the proximal surface of the tibia 20 to fill the joint space 3 and determine the medial gap distance md (FIG. 12B) and the lateral gap distance ld (FIG. 13B). Unlike the technique described above, the femoral trial 15a is not placed on the resected femur 10 during the connection transfer step.

The distal referencing technique is performed using the distal reference guide 15b. An exemplary embodiment of the assembled distal reference guide 15b is shown in FIG. 12A. The distal reference guide 15b has a femoral reference portion 44 having a medial local condylar portion 45M and a lateral local condylar portion 45L. Each condylar portion 45M, 45L has a complementary femoral engagement member 13. In the depicted exemplary embodiment, the complementary femoral engagement member 13 is a pin hole drilling 13b formed therethrough from anterior to posterior. Each pin hole drilling 13b can be accessed from the anterior for use in orienting the interlocking drill guide 30, as shown in FIG. 13A. The modular handle 41 is configured to be easily attached and detached from the femoral reference portion 44 for use in manipulating the distal reference guide 15b into and within the joint space 3. The distal portion of each of the condylar portions 45M, 45L is configured to receive a snap-on spacer 25b. Snap-on spacers 25b are provided in multiple thicknesses. The appropriate thickness of the snap-on spacer 25b is selected so that the fully assembled distal reference guide 15b matches the gap distance d determined in the previous step using the spoon gap spacer 25a (see FIG. 11).

FIG. 12B illustrates the use of a modular handle 41 to slide the distal reference guide 15b into the joint space 3. As shown in FIG. 12C, the modular handle 41 can be detached from the distal reference guide 15b after insertion, if desired.

As shown in FIG. 13A, with the distal reference guide 15b in place within the joint space 3, the interlocking drill guide 30 is inserted into the incision. The depicted exemplary embodiment of the interlocking drill guide 30 has a recess 39 in the femoral portion 32 of the interlocking drill guide 30 to allow a modular handle 41 to be inserted through the recess 39 to engage the distal reference portion 44 of the distal reference guide 15b, if desired. A pair of femoral engagement members 19, 19z in the form of orientation pins 19b are formed on or adjacent to the femoral portion 32 of the interlocking drill guide 30. It will be appreciated that in other exemplary embodiments, femoral connection holes 22, 22z, or other femoral engagement members 19 may be used in place of or in addition to the orientation pins 19b shown in FIG. 13A. The orientation pin 19b is inserted into the pin hole drillings 13b of the condyle portions 45M, 45L until the tibial portion 31 of the joint drill guide 30 contacts the anterior tibial cortex 21. In this manner, the exemplary distal reference joint drill guide assembly 1 is positioned in an engaged configuration. The joint drill guide 30 includes a pair of tibial reference holes 23, 23z on or adjacent to the tibial portion 31 of the joint drill guide 30.

Modified embodiments of the interlocking drill guide 30 and associated assemblies, systems, and methods described with reference to FIG. 13A are further contemplated. In such embodiments, the orientation pin 19b of the interlocking drill guide 30 can be inserted directly into a drill hole formed in the distal femur 10. The exemplary interlocking drill guide 30 can be sized to have an orientation pin 19b that extends into a drill hole formed through the distal femur resection guide 8 (see 15c in FIG. 16). In certain exemplary embodiments, the orientation pin 19b can be a spike configured to engage a drill hole in the distal femur 10. In such exemplary embodiments, the spike is the femoral engagement member 19 and the drill hole in the distal femur 10 is the complementary femoral engagement member 13.

As shown in FIG. 13B, a tibial linking pin 27 is placed into each of the tibial reference holes 23, 23z of the linking drill guide 30. As shown in FIG. 13C, a modular handle 41 can optionally be used at this step for stability. The tibial linking pin 27 is inserted into the tibia 20. In certain embodiments, the tibial linking pin 27 is threaded at the tip 11 (see FIG. 15).

As shown in FIG. 14A, the interlocking drill guide 30 and distal reference guide 15b are removed from the joint, leaving the tibial interlocking pin 27 in place in the proximal tibia 20. The receiving slot 87 of the pivoting tibial resection guide 40 is slid over the tibial interlocking pin 27. From this point on, the technique is similar to that described above, except that the femoral trial 15a is not on the resected distal femur 10. Note that once the interlocking pin 27 is placed in the tibia 20, the femoral trial 15a does not need to remain in place for any of the embodiments described herein.

As shown in the side view of FIG. 14B, the instrument may be sized so that the tibial resection level is automatically set to match the 10 mm tibial implant structure (i.e., tibial trial base 93 plus meniscal trial insert 95). In embodiments, the interlocking drill guide 30 may be fabricated to allow other resection levels as needed or desired by the surgeon, such as with multiple interlocking guides, multiple pin holes, or adjustable guides.

14C and with reference to FIG. 8, the tibial posterior slope PS can be adjusted as needed to match the natural anatomy in the manner described above. The pivoting tibial resection guide 40 is configured such that the pivoting tibial resection guide 40 can be adjusted relative to the placement of the tibial linking pin 27. In an embodiment, the pivoting tibial resection guide 40 can have a posterior slope angle θ ranging from about negative 3 degrees to about positive 10 degrees relative to the linking pin 27. Once the posterior slope angle θ is set, the pivoting tibial resection guide 40 can be locked at the selected posterior slope angle θ.

As described above with reference to FIG. 9, the pivoting tibial resection guide 40 is pinned in place through the standard pin hole 33. If desired, a flared fixation pin 34 can be used for added stability. The tibial linking pin 27 is removed.

As shown in FIG. 15, the proximal tibial resection is performed through the resection slot 46 of the pivoting tibial resection guide 40. Unlike the technique described above, there is no femoral trial 15a to remove prior to performing the tibial resection.

Once the tibial resection is complete, the surgeon selects the appropriately sized tibial base and tibial insert trial. The femoral trial 15a is placed on the previously resected distal femur 10. If a distal referencing technique as described herein is used, the femoral trial 15a may not have a complementary femoral engaging member 13, such as the complementary femoral engaging member 13 disclosed in Figures 1-9. A trial reduction is performed (see Figure 29). Femoral grooves, peg preps, and tibial keel preps can be performed according to the kinematic alignment technique or surgeon preference.

Distal Femoral Resection Guide Reference Technique FIGS. 16-28 generally illustrate exemplary devices and assemblies and method steps that may be involved in the use of the distal femoral resection guide 15c, including another embodiment of an exemplary interlocking drill guide 30.

16 is a perspective view of a knee in flexion. In the embodiment depicted in these figures, the femoral reference instrument 15 is a distal femoral resection guide 15c. The distal femoral resection guide 15c is slid over a femoral linking pin 17 that extends into the femur 10. In this embodiment, the femoral linking pin 27 is a standard pin that is otherwise used to identify the location of the distal femoral cut guide. The distal femoral resection guide 15c was positioned using kinematic alignment techniques known to surgeons. For example, the distal femoral resection guide assembly disclosed in U.S. Patent Application Publication No. 2019/0231365 (A1) may have been used to orient the distal femoral resection guide 15c. Once oriented, the surgeon uses the femoral linking pin 17 to lock the position and orientation of the distal femoral resection guide relative to the distal femur 10. The surgeon then inserts a surgical saw through the resection slot 57 and resects the distal surface of the femur 10, creating a distal resection surface 5 via a distal cut.

In the exemplary interlocking drill guide 30 depicted in FIG. 17A, the distal femoral resection guide 15c is then removed and the leg is placed in extension. It will be appreciated that the exemplary embodiment of the interlocking drill guide 30 used may affect which instrument functions as the femoral reference instrument 15. For example, in FIG. 17A, the femoral resection guide 15c has been removed and the femoral link pin 17, 15d remains in place on the femur 10. The femoral link pin 17 in the depicted embodiment functions as a type of femoral reference instrument 15, since the femoral link pin 17, along with the depicted embodiment of the interlocking drill guide 30, can be used to mechanically transfer information regarding the orientation of the distal resection surface 5 of the femur 10 to the tibial resection guide 40. Similarly, the distal femoral resection guide 15c is a type of femoral reference instrument 15, in which the slot 57 of the distal femoral resection guide 15c mechanically transmits information regarding the orientation of the distal resection surface 5 of the femur 10 to the tibial resection guide 40 when engaged with the blade 19c of the exemplary interlocking drill guide 30. In FIG. 17B, the distal femoral resection guide 15c is a type of femoral reference instrument 15.

17A includes a femoral portion 32. The femoral portion 32 includes a tube 24 that can receive a first femoral engagement member 19 and a second femoral engagement member 19z in the form of a femoral linking pin 17. That is, each tube 24 defines a linking hole 22 (see FIG. 5A). The tubes 24 and linking holes 22 can receive a femoral linking pin 17 in substantially the same manner as described above with reference to FIGS. 4 and 5A. In this manner, the depicted embodiment is configured to engage the first femoral engagement member 19 and the second femoral engagement member 19z. In the depicted embodiment, the first complementary femoral engagement member 13 and the second complementary femoral engagement member 13z are drill holes made directly in the distal femur 10. In FIG. 17A, the femoral linking pin 17 also functions as the first femoral engagement member 19 and the second femoral engagement member 19z. The distal femoral resection guide 15c has been removed, and the placement of the femoral linking pins 17 on the distal surface of the femur 10 retains information about the plane of distal resection that is coplanar with the distal resection surface 5. That is, an imaginary shortest possible line connecting the two femoral linking pins 17 can serve as a reference line parallel to the plane of distal resection of the femur 10.

The exemplary interlocking drill guide 30 further comprises a tibial portion 31 having a canal 24 defining the tibial reference holes 23, 23z, and a body 36 connecting the femoral portion 32 to the tibial portion 31. A handle 38 may be optionally provided to facilitate installation and removal of the interlocking drill guide 30. The handle 38 may be removable, or the handle 38 may be a permanent and integral part of the interlocking drill guide 30. The body 36 of the interlocking drill guide 30 conveys information regarding the orientation of the distal resection plane (coplanar with the distal resection surface 5) for the tibial portion 31 of the interlocking drill guide 30.

As better seen in FIGS. 18, 19A, and 19B, the distal end 16 of the tube 24 defines the tibial reference hole 23, 23z. The distal end 16 of each of the tubes 24 is preferably recessed from the posterior distal end 18 of the tibial portion 31 of the interlocking drill guide 30. When the interlocking drill guide 30 is in the engaged configuration, the inferior surface 53 (FIG. 19B) of the tibial portion 31 aligns with the tibial resection plane. This feature allows the surgeon to visualize the tibial resection cut before it is made. The recess 39 also allows for direct marking of the tibia 20 by creating a line connecting the two opposing inferior surfaces 53 at the distal end 18 of the tibial portion 31. Direct marking is typically performed with a surgical grade single-use marker or through a cauterization device. If desired, a line may be made drawn through the recess 39 separating the opposing inferior surfaces 53 at the distal end 18 of the tibial portion 31.

18 further shows an expansion device 49, such as a gap spacer 25, inserted into the joint gap 3 to confirm and verify the medial and lateral distances between the resected distal condyle of the femur 10 and the medial and lateral condyles of the adjacent proximal tibial plateau 20 of the same leg. Instead of the distal reference gap spacer 25, a lamina spreader or other tensioning device may be used to tension the joint. Once determined, the surgeon inserts the tibial linking pin 27, as depicted in FIG. 19A.

20A shows the tibial linking pin 27 remaining positioned on the proximal surface of the anterior cortex 21 of the tibia 20 after the linking drill guide 30 has been removed. As seen in FIGS. 21A and 22, the receiving slot 87 of the pivoting tibial resection guide 40 can then be slid over the remaining tibial linking pin 27. The locking mechanism 48 is in an unlocked position. A visual indicator can be provided on the front surface of the locking mechanism 48 to inform the surgeon of which position the locking mechanism 48 is in. In the depicted embodiment, an indicator located at the 9 o'clock position indicates that the locking mechanism 48 is unlocked. The posterior slope PS (see FIG. 8) can then be adjusted and the proximal surface of the tibia 20 can be resected as described above (also see generally FIGS. 23-28).

17B, another exemplary embodiment of the interlocking drill guide 30 is provided. In the depicted embodiment of the associated distal reference interlocking drill guide assembly 1, the distal femoral resection guide 15c can be seen to function as the femoral reference instrument 15. The femoral resection slot 57 also functions as the first complementary femoral engagement member 13 of the femoral reference instrument 15. The first femoral engagement member 19 on the femoral portion 32 of the interlocking drill guide 30 is a blade 19c that is sized to fit closely within the femoral resection slot 57. In the depicted embodiment, a recess 39 may be present in the tibial portion 31 of the interlocking drill guide 30. The recess 39 allows the interlocking drill guide 30 to be slid over the stem portion 51 of the distal femoral resection guide 15c.

The blade 19c of the interlocking drill guide 30 is slid into the femoral resection slot 57 of the distal femoral resection guide 15c with the leg in extension. FIG. 19B shows the tibial interlocking pin 27 being inserted into the tibial reference hole 23. It is then possible to proceed as outlined in FIGS. 21A and 22 and described above.

20B shows a spike plate 67 used as a reference instrument for the pivoting tibial resection guide 40 in place of the tibial linking pin 27. As shown in FIGS. 19A and 19B, the tibial linking pin 27 is inserted through the tibial reference holes 23, 23z in the tibial portion 31 of the linking drill guide 30 and screwed into the anterior cortex 21 of the proximal tibia 20. In FIG. 20B, both the linking drill guide 30 and the tibial linking pin 27 have been removed, thereby leaving a drill hole in the anterior cortex 21 of the proximal tibia 20. A spike plate 67 is provided that includes a first spike member 61 and a second spike member 62 connected by a body portion 63 and having a linking tab 64 for facilitating selective engagement to the pivoting tibial resection guide 40. As will be further described below, the linking tab 64 can represent an orientation of a plane otherwise defined by the compound axis of the tibial linking pin 27. The first spike member 61 and the second spike member 62 of the spike plate 67 are inserted into the tibial drill hole left by the connecting tibial pin 27.

In certain exemplary embodiments, the spike plate 67 may be a single-use disposable item. In other exemplary embodiments, the spike plate may be made from stainless steel or any other clinically proven biocompatible material having sufficient strength and durability.

As seen in FIG. 21B, the pivoting tibial resection guide 40 with the reference slot 41 is slid over the linking tab 64 of the spike plate 67. The linking tab 64 is visible through the open resection slot 41. The linking tab 64 is oriented parallel to the resection slot 46, thereby indicating the orientation of the plane otherwise formed by the compound axis of the tibial linking pin 27 (see PS in FIG. 8). To better facilitate the surgeon's pre-visualization of the tibial resection cut, which is made in a parallel plane above the plane otherwise formed by the compound axis of the tibial linking pin 27, the linking tab 64 may optionally be provided with a visual indicator, such as a different color than the surrounding instrumentation. The surgeon can lock the linking tab 64 to the reference slot 41 using the locking mechanism 48 on the anterior end of the pivoting tibial resection guide 40. In FIG. 21B, the locking mechanism 48 is shown in the unlocked position.

The spike plate 67 allows for medial and lateral positioning of the pivoting tibial resection guide 40 as well as inward and outward rotation of the pivoting tibial resection guide 40, whereas the use of the tibial linking pin 27 precludes medial and lateral positioning of the pivoting tibial resection guide 40.

23-25 show a tibial visual tilt gauge 60 that may be optionally positioned in the resection slot 47 of the pivoting tibial resection guide 40. The posterior tilt angle θ of the tibial resection guide 40 may be adjusted from about -3° to about +10° relative to the placement of the tibial linking pin 27, or in embodiments involving the use of a spike plate 67, relative to the placement of the spike plate 67. Once the desired tilt and orientation is achieved, the pivoting motion may be locked by rotating the locking mechanism 48.

The locking mechanism 48 depicted in the cross-sectional views of FIG. 21B and FIG. 30 is in an unlocked position. The locking mechanism 48 may be a friction locking mechanism such as that depicted in FIG. 30, although other locking mechanisms configured to selectively fix the orientation of the pivoting tibial resection guide 40 are considered within the scope of the present disclosure. For example, a mechanical locking mechanism 48 may be provided in certain exemplary embodiments.

30 and further with reference to FIG. 27, the surgeon or technician can lock the locking mechanism by inserting a keyed instrument through the interface of the locking mechanism 48. The keyed instrument may be a screwdriver, hex wrench, or other keyed instrument having a keyed end of any shape that is sized to closely engage a complementary key shape in the interface that is in rotational communication with the cam 73. When the keyed instrument is rotated, the interface rotates the cam 73 in the same direction. The cam 73 converts the rotational force into a linear force by pushing the cam follower 74 against the spring 75. The spring 75 then transmits the linear force to the shaft 71, which then transmits the linear force as friction to the pivot guide 66. The application of this friction thereby prevents the pivot assembly 55 from rotating about its axis. In this manner, the surgeon or technician is said to "lock" the pivoting tibial resection guide at the desired posterior tilt angle θ.

It will be appreciated that in embodiments including the tibial link pin 27, the tibial link pin 27 extends through the tibial engagement hole 68a of the pivot guide 66 to selectively engage the pivoting tibial resection guide 40 to the tibia 20. The tibial engagement hole 68a generally aligns with the receiving slot 87 of the pivoting tibial resection guide 40. Similarly, in embodiments including the link tab 64, the slot 68b of the pivot guide 66 is desirably sized to receive the link tab 64 of the spike plate 67.

26, the inclination gauge is removed after the inclination of the pivoting tibial resection guide 40 is set. A standard pin 37 is then placed through the standard pin hole 33 in the pivoting tibial resection guide 40. The pivoting tibial resection guide 40 may be moved to a position +2 mm from the standard hole if desired. The locking mechanism 48 is shown in the locked position. In the depicted embodiment, a visual indicator at the 12 o'clock position indicates that the locking mechanism 48 is locked. Other visual indicators that indicate the position of the locking mechanism are considered within the scope of this disclosure.

FIG. 27 shows the pivoting tibial resection guide 40 positioned at the desired posterior slope PS (see FIG. 8) and further depicts the flared fixation pin 34 extending through the pivoting tibial resection guide 40 to further secure the pivoting tibial resection guide 40 to the tibia 20 at the desired slope. The resection slot 46 of the pivoting tibial resection guide 40 orients the resection plane of the proximal end 29 of the proximal tibia 20.

Figure 28 depicts the pivoting tibial resection guide 40 positioned at the desired posterior slope PS (see Figure 8) and the proximal end 29 (Figure 27) of the proximal tibia 20 has been resected.

29 is a perspective view of the femoral trial 15a, tibial trial base 93, and meniscal trial insert 95 that have been selected based on size criteria. Without being bound by theory, it is contemplated that the exemplary distal reference interlocking drill guide 30 and/or exemplary distal reference interlocking drill guide assembly 1 described herein can directly interlock the orientation of the distal cut (resulting in the distal resection surface 5 of the distal femur 10) to the orientation of the proximal cut of the proximal tibia 20, thereby significantly reducing the possibility of surgeon error while further eliminating one or more extra steps otherwise required by conventional independently referenced or indirectly interlocking kinematic alignment techniques. The minimal size of the exemplary distal reference interlocking drill guide 30 and exemplary distal reference interlocking drill guide assembly 1 allows the interlocking drill guide 30 and drill guide assembly 1 to fit into the surgical field without requiring additional instrumentation that extends significantly outside the incision. It is contemplated that the minimal amount of instrumentation may facilitate instrument resterilization between procedures.

The instruments may be provided in the form of a kit. The components of the kit are preferably arranged in a convenient format, such as a surgical tray or case. However, the kit components need not be packaged or delivered together, provided that they are assembled or collected together in an operating room for use during surgery. An exemplary kit may include any suitable embodiment of the interlocking drill guide 30, any variation of the interlocking drill guide 30 described herein, and any other interlocking drill guide 30 according to an embodiment. While it is contemplated that an exemplary kit may further include one or more femoral engagement members 19, 19z, etc., one or more tibial engagement members 77, 77z, etc., and one or more femoral reference instruments 15, it will be understood that a particular kit may lack some or all of these elements. Any suitable embodiment of the femoral engagement member 19, any variation of the femoral engagement member 19 described herein, and any other femoral engagement member 19 according to an embodiment are considered to be within the scope of the present disclosure. Any suitable embodiment of the tibial engagement member 77, variations of the tibial engagement member 77 described herein, and any other tibial engagement member 77 according to an embodiment are considered to be within the scope of this disclosure. Any suitable embodiment of the femoral reference instrument 15, variations of the femoral reference instrument 15 described herein, and any other femoral reference instrument 15 according to an embodiment are considered to be within the scope of this disclosure.

Selecting the appropriate number or type of interlocking drill guides 30, femoral engagement members 19, tibial engagement members 77, and femoral reference instruments 15 to include in a kit according to a particular embodiment can be based on various considerations, such as the procedure intended to be performed using the components included in the kit.

An exemplary medical device may include a femoral portion configured to engage a first femoral engagement member, a tibial portion configured to engage a first tibial engagement member, and a body connecting the femoral portion to the tibial portion.

In such an exemplary medical device, the first femoral engagement member can be selected from the group consisting essentially of a femoral link pin, a blade, a slot, a lip, a clamp, a hook, a protrusion, a recess, a spike, a magnet, an orientation pin, and combinations thereof.

In such an exemplary medical device, the first tibial engagement member can be selected from the group consisting essentially of holes, slots, recesses, protrusions, clamps, lips, magnets, spikes, and combinations thereof.

An exemplary distal reference interlocking drill guide assembly may include an interlocking drill guide including a femoral portion configured to engage a first femoral engagement member, a tibial portion configured to engage a first tibial engagement member, and a body connecting the femoral portion to the tibial portion, and a femoral reference instrument having a first complementary femoral engagement member configured to engage the first femoral engagement member, wherein the distal reference interlocking drill guide assembly has an engaged configuration when the first femoral engagement member engages the first complementary engagement member, and the distal reference interlocking drill guide assembly has a disengaged configuration when the first femoral engagement member does not engage the first complementary engagement member.

Such an exemplary assembly may further include an expansion device configured to be placed between the resected distal femur and the proximal tibia to confirm the distance between the distal femur and the proximal tibia. The expansion device may be selected from the group consisting essentially of a gap spacer, a laminar spreader, a ratchet tensioner, or other knee ligament tensioning device.

Such an exemplary assembly may include a femoral portion further configured to engage a second femoral engagement member, and the femoral reference instrument may further include a second complementary femoral engagement member configured to engage the second femoral engagement member. The second femoral engagement member may be configured to selectively engage the second complementary femoral engagement member.

Such an exemplary assembly can have a femoral reference instrument selected from the group consisting essentially of a femoral trial, a distal reference guide, a pin, and a distal femoral cut guide.

Such an exemplary assembly may include a tibial portion of the interlocking drill guide further configured to engage a second tibial engagement member.

Such an exemplary assembly can have an engagement configuration that includes a first femoral engagement member that directly engages a first complementary femoral engagement member.

Such an exemplary assembly can have an engagement configuration that includes a first femoral engagement member that indirectly engages a first complementary femoral engagement member.

Such an exemplary assembly may have a first femoral engagement member selected from the group consisting essentially of a femoral link pin, a blade, a slot, a lip, a clamp, a hook, a protrusion, a recess, a spike, a magnet, an orientation pin, and combinations thereof.

Such an exemplary assembly may have a first tibial engagement member selected from the group consisting essentially of holes, slots, recesses, protrusions, clamps, lips, magnets, spikes, and combinations thereof.

An exemplary medical device may include a femoral portion having a blade sized to fit closely within a femoral resection slot of a distal femoral resection guide, a tibial portion having a canal defining a tibial reference hole, and a body connecting the femoral portion to the tibial portion.

Such an exemplary assembly may further include a handle engaged with the body.

Such an exemplary assembly may have a tube recessed from the posterior distal end of the tibial portion of the interlocking drill guide, the tube defining the tibial reference hole.

Such an exemplary assembly can have an inferior surface of the tibial portion that aligns with the tibial resection plane when the interlocking drill guide is in the engaged configuration.

Another exemplary medical device may include a femoral portion having a first femoral engagement member, a tibial portion configured to engage the first tibial engagement member, and a body connecting the femoral portion to the tibial portion.

Yet another exemplary medical device may include a femoral portion having a first femoral engagement member, a tibial portion having a first tibial engagement member, and a body connecting the femoral portion to the tibial portion.

An exemplary method may include engaging a femoral reference instrument to a distal femur, directly or indirectly engaging a first femoral engagement member to the distal femur, and directly or indirectly engaging a coupling drill guide to the first femoral engagement member, where the coupling drill guide includes a femoral portion configured to engage the first femoral engagement member, a tibial portion configured to engage the first tibial engagement member, and a body connecting the femoral portion to the tibial portion.

In an exemplary method, the step of directly engaging the first femoral engaging member to the distal femur can include physically contacting the first femoral engaging member to the anterior cortex of the distal femur.

In an exemplary method, the step of indirectly engaging the first femoral engaging member to the distal femur can include physically contacting the first femoral engaging member to a first complementary engaging member on a mid-femoral device, where a portion of the mid-femoral device physically contacts the distal femur.

In an exemplary method, the step of indirectly engaging the first femoral engaging member to the distal femur can further include physically contacting the first femoral engaging member to a first complementary engaging member on an intermediate device. A portion of the intermediate device can be in physical contact with a subsequent intermediate device, and a portion of the subsequent intermediate device can be in physical contact with the distal femur.

The exemplary method may further include inserting an expansion device into a joint space defined by the distal and proximal femurs of the operative leg to ascertain a distance between the distal femur and the proximal tibia. The distance includes a medial distance and a lateral distance.

An exemplary method may further include using a traction device to retract the operative leg and apply traction to the proximal tibia or distal femur to expand the joint space.

The exemplary method may further include directly or indirectly engaging a first tibial engagement member to both the proximal tibia and the tibial portion of the interlocking drill guide.

In an exemplary method, the step of directly engaging the first tibial engagement member to the proximal tibia can include physically contacting the first tibial engagement member to the anterior cortex of the proximal tibia.

In an exemplary method, the step of indirectly engaging the first tibial engagement member to the proximal tibia can include physically contacting the first tibial engagement member to a medial tibial device. A portion of the medial tibial device can be in physical contact with the proximal tibia.

In an exemplary method, the step of indirectly engaging the first tibial engagement member to the proximal tibia can further include physically contacting the first tibial engagement member to a medial tibial device. A portion of the medial tibial device can be in physical contact with the subsequent medial tibial device, and a portion of the subsequent medial tibial device can be in physical contact with the proximal tibia.

The exemplary method may further include removing the coupling drill guide from the first tibial engagement member while the first tibial engagement member remains directly or indirectly engaged to the proximal tibia.

The exemplary method may further include engaging the tibial resection guide to the first tibial engagement member.

The exemplary method may further include adjusting a posterior inclination angle of the tibial resection guide relative to the position of the first tibial engagement member to define a desired resection inclination.

The exemplary method may further include fixedly locking the tibial resection guide to the proximal tibia at the desired resection inclination.

The exemplary method may further include resecting the tibial plateau of the proximal tibia at a desired resection slope.

The exemplary method may further include adjusting the height of the tibial resection guide relative to the top of the proximal tibia to accommodate the height of the endoprosthetic implant assembly.

An exemplary method may further include adjusting a medial/lateral angle of the tibial resection guide relative to the first tibial engagement member to define a desired medial/lateral resection angle.

The exemplary method may further include fixedly locking the tibial resection guide to the proximal tibia at the desired medial/lateral resection angle.

The exemplary method may further include resecting the tibial plateau of the proximal tibia at a desired medial/lateral resection angle.

The exemplary method may further include adjusting a medial/lateral position of the tibial resection guide relative to the first tibial engagement member to define a desired medial/lateral resection position.

The exemplary method may further include fixedly locking the tibial resection guide to the proximal tibia at the desired medial/lateral resection location.

The exemplary method may further include resecting the tibial plateau of the proximal tibia at the desired medial/lateral resection location.

It is to be understood that the invention is not limited to the particular configurations and method steps disclosed herein or illustrated in the drawings, but includes any modifications or equivalents known in the art that are within the scope of the claims. Those skilled in the art will appreciate that the apparatus and methods disclosed herein will find utility.

Claims (6)

a femoral portion including a blade engaging and extending from a posterior distal end of the femoral portion, the blade being sized to fit snugly within a femoral resection slot of a distal femoral resection guide;
a tibial portion having a tube protruding from an underside of the tibial portion, the tube defining a tibial reference hole;
a body connecting the femoral portion to the tibial portion, the distal end of each tube being set back from a posterior distal end of the tibial portion of the medical device ;
A medical device comprising: The medical device of claim 1, further comprising a handle that engages the body. The medical device of claim 1 , wherein the inferior surface of the tibial portion coincides with the tibial resection surface when the medical device is in the engaged configuration. a femoral portion configured to engage with the first femoral engaging member;
a tibial portion having a first arm disposed opposite a second arm, the first arm defining a recess extending from a posterior distal side of the tibial portion separating the first arm from the second arm, the first arm and the second arm each having a tube protruding from an underside of the first arm and the second arm of the tibial portion, the tube defining a tibial reference hole;
a body connecting the femoral portion to the tibial portion;
Equipped with
A medical device in which a distal end of each tube is recessed from a posterior distal end of the tibial portion of the medical device, and when the medical device is in an engaged configuration, an underside of the first arm and the second arm of the tibial portion coincides with a tibial resection surface. The medical device of claim 4, wherein the first femoral engagement member is selected from the group consisting essentially of a femoral link pin, a blade, a slot, a lip, a clamp, a hook, a protrusion, a recess, a spike, a magnet, an orientation pin, and combinations thereof. The medical device of claim 4 , further comprising a handle engaging the body.